Fast Titration Of Quetiapine Versus Currently Approved Titration

This study has been completed.

First Received: November 15, 2005 Last Updated: December 14, 2007 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00254813

Purpose

The purpose of this study is to evaluate the safety and tolerability of a more rapid dose titration in acute schizophrenic patients compared to the conventional titration.

Condition	Intervention	Phase
Psychotic Disorders	Drug: Quetiapine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Proportion of patients with moderate and severe adverse events

Secondary Outcome Measures:

Mean daily level of somnolence and orthostatic dizziness as rated on AE intensity scale

Estimated Enrollment:	150
Study Start Date:	March 2004
Study Completion Date:	September 2005

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent, male or female between 18 and 60 years old, having acute exacerbation of their schizophrenia or schizoaffective disorder requiring admission to hospital. Should stay in hospital for at least 7 days.

Exclusion Criteria:

Patients treated with Risperdal consta or Clozapine last 28 days, pregnancy or breast-feeding, patients known to be intolerant or unresponsive to quetiapine, known arrhythmia, other serious medical conditions.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254813

Locations

Norway
Research Site
Oslo, Norway
Research Site
Ålesund, Norway
Research Site
Arendal, Norway
Research Site
OTTESTAD, Norway
Research Site
Kristiansand, Norway
Research Site
Nesttun, Norway
Research Site
KLEPP STASJON, Norway

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Norway Medical Director, MD

AstraZeneca

More Information

Additional Information:

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D1449L00003
Study First Received:	November 15, 2005
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00254813 History of Changes
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by AstraZeneca:

Schizophrenia
Schizoaffective disorder

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Disease
Tranquilizing Agents
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions

Quetiapine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 02, 2009